510(k) K073163
K073163 is an FDA 510(k) premarket notification submitted by Dinkler Surgical Devices, Inc. for the device "LIMITED ARTIFACT SKULL PIN, MODEL 0107". The FDA issued a decision of Substantially Equivalent on February 28, 2008. The device falls under product code HBL (Holder, Head, Neurosurgical (Skull Clamp)), a Class II device regulated under 21 CFR 882.4460. Dinkler Surgical Devices, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 2008
- Date Received
- November 9, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Holder, Head, Neurosurgical (Skull Clamp)
- Device Class
- Class II
- Regulation Number
- 882.4460
- Review Panel
- NE
- Submission Type